Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04517604
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2020-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy.herrold@va.gov', 'phone': '708-202-5867', 'title': 'Dr. Amy Herrold', 'organization': 'Edward Hines Jr., VA Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The main limitations were the small sample size, open-label design, and lack of a control group. As this was a pilot we did not assess for multiple comparisons. Our satisfaction ratings and qualitative interviews assessing acceptability may be biased as they were only done for those completing all 6 intervention sessions.'}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'Safety data on safety indicators was collected at each iTBS session including the following: hypertension, hypotension, heart rate, oxygen saturation, sleep, fatigue medication changes, seizure, headache/neck pain, fever, fainting, scalp/skin breakdown, tinnitus, dizziness, nausea, vomiting, confusion, and contraindicated substance use.\n\nAdverse event reporting logs were completed and reported to the IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label iTBS+Yoga', 'description': 'All patients received individual approximately 3-minute iTBS session followed by a 90-minute group LoveYourBrain yoga session. iTBS+yoga sessions occurred once a week for 6 weeks.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'notes': '3 individuals had headaches, resulting in 1 participant self-withdrawing. For this person, the headaches started \\~3 days after the first session. This participant had a history of occasional unlocalized headaches.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Session Completion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'number of sessions', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iTBS+Yoga', 'description': 'Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.\n\nMagventure MagProx100 with MagOption: The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Endpoint - after last iTBS+yoga session, approximately 6 weeks', 'description': 'For feasibility, we will track the number of iTBS+yoga sessions completed and compute completion percentage rates for each participant as a metric of feasibility.', 'unitOfMeasure': 'number of sessions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of sessions', 'denomUnitsSelected': 'number of sessions', 'populationDescription': '14 participants initiated iTBS+yoga treatment sessions and could possibly complete 6 total number of intervention sessions. Thus total number of possible sessions is 14 x 6 = 84'}, {'type': 'SECONDARY', 'title': 'Mayo-Portland Adaptability Index - Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label iTBS+Yoga', 'description': 'All patients received individual approximately 3-minute iTBS session followed by a 90-minute group LoveYourBrain yoga session. iTBS+yoga sessions occurred once a week for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'spread': '17.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.343', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.02', 'ciLowerLimit': '-16.52', 'ciUpperLimit': '6.47', 'pValueComment': 'no adjustment for multiple comparisons as was a pilot', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.984', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)', 'description': 'The Mayo-Portland Adaptability Index is a TBI Common Data Element assessment of function and participation. It includes 35 items each scored on a scale of 0 to 4, with 0 meaning no problems (better), and 4 meaning severe problems (worse). Minimum (best) score would be 0 and maximum (worst) score would be 140.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis completed on the 10 iTBS+yoga treatment completers'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory - Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label iTBS+Yoga', 'description': 'All patients received individual approximately 3-minute iTBS session followed by a 90-minute group LoveYourBrain yoga session. iTBS+yoga sessions occurred once a week for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.0026', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.63', 'ciUpperLimit': '-.77', 'pValueComment': 'no test for multiple comparisons as this was a pilot study', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '.42', 'groupDescription': 'This was an open-label, single group study using a within subject design. We compared pre-treatment values to post-treatment values.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This was a pilot study funded under a pilot funding mechanism which specifically did not require a power analysis.'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)', 'description': 'The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 4 main items and each item is scored on a scale of 0 to 10 with 0 meaning no pain (better), and 10 meaning pain as bad as you can imagine (worse). Minimum (best) score would be 0 and maximum (worst) score would be 40.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis completed on the 10 iTBS+yoga treatment completers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iTBS+Yoga', 'description': 'Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.\n\nMagventure MagProx100 with MagOption: The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'We recruited treatment-seeking Veterans from Edward Hines Jr., VA Hospital Recruitment Period: 6/2021 to 6/2023 Types of Location: Suburban VA Hospital and associated relevant clinics such as the Polytrauma/TBI clinic.', 'preAssignmentDetails': 'Participants were screened over the phone with a delimited set of measures but more in-depth screening for full eligibility criteria occurred after consent/enrollment. Thus, only enrolled participants meeting full eligibility criteria were allowed to move forward and assigned to receive the treatment intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label iTBS+Yoga', 'description': 'All patients received individual approximately 3-minute iTBS session followed by a 90-minute group LoveYourBrain yoga session. iTBS+yoga sessions occurred once a week for 6 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': 'cisgender men', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'cisgender women', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'transgender men', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'transgender women', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Brief Pain Inventory - Pain Severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.59', 'spread': '1.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '4 main items and each item is scored on a scale of 0 to 10 with 0 meaning no pain, and 10 meaning pain as bad as you can imagine. Minimum (best) score for all 4 items would be 0 and maximum (worst) score would be 40.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants that completed baseline assessments are included which is an n=14.'}, {'title': 'Brief Pain Inventory - Pain Interference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.24', 'spread': '2.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '7 main items and each item is scored on a scale of 0 to 10 with 0 meaning does not interfere, and 10 meaning completely interferes. Minimum (best) score for all 7 items would be 0 and maximum (worst) score would be 70.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who completed baseline measures are included which is an n=14.'}, {'title': 'Mayo-Portland Adaptability Inventory (MPAI-4) - Total', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.3', 'spread': '9.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mayo-Portland Adaptability Inventory (MPAI-4) Total T-Score. The Total raw score is converted to a T-score using a national sample conversion chart provided in the MPAI-4 manual. Mean = 50, Standard deviation = 10. Higher scores represent worse function and lower scores indicate better function.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who participated in baseline assessments are reported which is an n=14.'}, {'title': 'Mayo-Portland Adaptability Inventory (MPAI-4) - Ability', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.7', 'spread': '9.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mayo-Portland Adaptability Inventory (MPAI-4) Ability Index Subscale T-Score. The Ability Index Subscale raw score is converted to a T-score using a national sample conversion chart provided in the MPAI-4 manual. Mean = 50, Standard deviation = 10. Higher scores represent worse function and lower scores indicate better function.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who completed baseline assessments are included which is an n=14.'}, {'title': 'Mayo-Portland Adaptability Inventory (MPAI-4) - Participation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.5', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mayo-Portland Adaptability Inventory (MPAI-4) Participation Index Subscale T-Score. The Participation Index Subscale raw score is converted to a T-score using a national sample conversion chart provided in the MPAI-4 manual. Mean = 50, Standard deviation = 10. Higher scores represent worse function and lower scores indicate better function.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who completed baseline assessments which is an n=14 are included.'}, {'title': 'Mayo-Portland Adaptability Inventory (MPAI-4) - Adjustment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.7', 'spread': '7.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mayo-Portland Adaptability Inventory (MPAI-4) Adjustment Index Subscale T-Score. The Adjustment Index Subscale raw score is converted to a T-score using a national sample conversion chart provided in the MPAI-4 manual. Mean = 50, Standard deviation = 10. Higher scores represent worse function and lower scores indicate better function.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants that completed baseline assessments are included which is an n=14.'}], 'populationDescription': '19 participants enrolled, 14 initiated iTBS+yoga sessions, and 10 completed all sessions'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-01', 'size': 836894, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-18T12:21', 'hasProtocol': True}, {'date': '2022-02-23', 'size': 317415, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-18T12:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intermittent Theta Burst Stimulation (iTBS) in combination with Love Your Brain Yoga Program. 6 weekly sessions of iTBS given prior to small group yoga.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'dispFirstSubmitDate': '2024-08-28', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2020-07-17', 'resultsFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2020-08-13', 'dispFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-15', 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Session Completion Rate', 'timeFrame': 'Endpoint - after last iTBS+yoga session, approximately 6 weeks', 'description': 'For feasibility, we will track the number of iTBS+yoga sessions completed and compute completion percentage rates for each participant as a metric of feasibility.'}], 'secondaryOutcomes': [{'measure': 'Mayo-Portland Adaptability Index - Total', 'timeFrame': 'Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)', 'description': 'The Mayo-Portland Adaptability Index is a TBI Common Data Element assessment of function and participation. It includes 35 items each scored on a scale of 0 to 4, with 0 meaning no problems (better), and 4 meaning severe problems (worse). Minimum (best) score would be 0 and maximum (worst) score would be 140.'}, {'measure': 'Brief Pain Inventory - Pain Severity', 'timeFrame': 'Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)', 'description': 'The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 4 main items and each item is scored on a scale of 0 to 10 with 0 meaning no pain (better), and 10 meaning pain as bad as you can imagine (worse). Minimum (best) score would be 0 and maximum (worst) score would be 40.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['traumatic brain injury', 'concussion', 'chronic pain', 'pain', 'neuromodulation', 'transcranial magnetic stimulation', 'intermittent theta burst stimulation', 'yoga'], 'conditions': ['Mild Traumatic Brain Injury', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '35704372', 'type': 'DERIVED', 'citation': 'Krese KA, Donnelly KZ, Etingen B, Bender Pape TL, Chaudhuri S, Aaronson AL, Shah RP, Bhaumik DK, Billups A, Bedo S, Wanicek-Squeo MT, Bobra S, Herrold AA. Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial. JMIR Res Protoc. 2022 Jun 15;11(6):e37836. doi: 10.2196/37836.'}]}, 'descriptionModule': {'briefSummary': "The objectives of this VA SPiRE application are to develop a combined neuromodulation and yoga (iTBS+yoga) intervention for Veterans with mild traumatic brain injury (mTBI) and chronic pain, assess the intervention's feasibility and acceptability, and to gather preliminary clinical outcome data on quality of life, function and pain that will guide future studies. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. Neuromodulation is now offered at 30 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain.", 'detailedDescription': "Over 340,000 people have incurred a mild traumatic brain injury (mTBI) as a result of the military conflicts in Iraq and Afghanistan. mTBI leads to a host of poor rehabilitation outcomes including impairments in cognition, physical health, and psychological health. These impairments among people with TBI lead to poor quality of life (QOL). Worsening this clinical picture, the prevalence of chronic pain is estimated to be 51.5% among civilians with TBI and 43.1-70% among Veterans with TBI. Opioids are used for treating chronic pain including among people with TBI. Thus, given the ongoing opioid epidemic in the United States, it is very timely to develop alter-native, non-pharmacologic treatments for chronic pain among Veterans with mTBI. Yoga is a promising activity-based intervention for TBI and chronic pain. Yoga is an activity generally comprised of breathing exercises, gentle stretching, and meditation. Neuromodulation through transcranial magnetic stimulation (TMS) is a prom-ising non-invasive, non-pharmacological treatment for TBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS shows promise to prime the brain for combined interventions and may magnify the impacts that these interventions would have when used alone, in order to boost outcomes. The purpose of this SPiRE project is to develop a novel, combined neuromodulation and yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain, and to examine the intervention's feasibility and acceptability. Using an existing, evidence-based, yoga program created specifically for people with TBI (LoveYourBrain Yoga), the investigators will first develop a neurorehabilitation intervention that combines iTBS with yoga (iTBS+yoga), and then collect pilot data about its feasibility and acceptability. Aim 1 will develop a novel, combined iTBS+yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain. Aim 2 will examine the feasibility and acceptability of the iTBS+yoga intervention for Veterans with mTBI and chronic pain. Aim 3 will gather preliminary data to provide the foundation for sample size and power considerations for a future clinical trial to examine the effectiveness of iTBS+yoga on Veterans' quality of life, function and pain out-comes. The combined intervention will be provided in small group settings once a week for 6 weeks. iTBS will be administered immediately prior to the LoveYourBrain Yoga session. Emphasizing National Institute of Neuro-logical Disorders and Stroke (NINDS) Traumatic Brain Injury Common Data Elements (TBI CDEs), the investigators will collect preliminary outcome data related to quality of life, function and pain to inform a future Merit application, should the intervention prove feasible. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. TMS is now offered at 30 VA hospitals nationwide for treatment-resistant depression, and yoga is among the complementary and integrative health programs being rolled out as a part of VAs nation-wide Whole Health implementation efforts, with classes offered through VA service lines such as recreational therapy. Therefore, should iTBS+yoga ultimately prove to be efficacious and effective, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain, increased risk of opioid therapy, and increased risk of developing opioid use disorders."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 22+ years of age\n* Can read and speak English\n* Perceive themselves as able to participate in gentle physical movements and cleared by study physician to do so.\n* mTBI Criteria: Symptom Attribution and Classification (SACA) criteria for mTBI (without requirement of clinical neuropsychological impairment)\n* Chronic pain: pain that persists for \\>6 months and is of moderate to severe intensity with a score of \\>5 on specific items on the Brief Pain Inventory (BPI)\n* Fully vaccinated against COVID-19 prior to study participation\n\nExclusion Criteria:\n\n* Contraindications to iTBS/TMS (e.g. epilepsy, history of anoxic brain injury or heart disease)\n* Contraindications to MRI (e.g., claustrophobia, ferromagnetic metal implants)\n* Pain believed to be associated with cardiac or ischemic conditions\n* Active seizure disorder, or if they are taking psychostimulants (e.g. amphetamines), anticholinergics or other medications that may increase their risk of having seizures\n* History of moderate to severe TBI\n* History of or current psychosis not due to an external cause (e.g., due to illicit drug use)\n* Are pregnant or nursing\n* Within 12 weeks of a major surgery/operation\n* Have questionably valid test profiles'}, 'identificationModule': {'nctId': 'NCT04517604', 'briefTitle': 'Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain', 'orgStudyIdInfo': {'id': 'N3611-P'}, 'secondaryIdInfos': [{'id': 'I21RX003611', 'link': 'https://reporter.nih.gov/quickSearch/I21RX003611', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iTBS+yoga', 'description': 'Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.', 'interventionNames': ['Device: Magventure MagProx100 with MagOption']}], 'interventions': [{'name': 'Magventure MagProx100 with MagOption', 'type': 'DEVICE', 'description': 'The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.', 'armGroupLabels': ['iTBS+yoga']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60141-3030', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines Jr. VA Hospital, Hines, IL', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}], 'overallOfficials': [{'name': 'Amy A Herrold, PhD BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward Hines Jr. VA Hospital, Hines, IL'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After primary publication of study data.', 'ipdSharing': 'YES', 'description': 'A de-identified data set will be created and shared.Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available. These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.\n\nThe data provided will be sufficient for anyone to perform analogous or supplemental analyses that would permit validation of the analysis and results. The sharing of data will enable others to evaluate the data and to validate and interpret the data independently. In order to insure that replication is possible and transparency, statistical code complementary to datasets will be made available through the Federal Interagency Traumatic Brain Injury Research Informatics System.', 'accessCriteria': 'These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}